Motion Filed to Consolidate Pradaxa Litigation in MDL

A motion has been filed to consolidate the Pradaxa litigation in the federal court system as part of an MDL (multidistrict litigation), centralizing all product liability lawsuits over the anticoagulant that have been filed in U.S. District Courts throughout the United States.

There are currently at least 21 different lawsuits pending in 12 federal district courts against Boehringer Ingelheim, all involving similar allegations that the drug maker failed to adequately warn about the side effects of Pradaxa, which caused plaintiffs or their loved ones to suffer serious injuries or death from bleeding problems that could not be stopped.

In a motion (PDF) filed with the U.S. Judicial Panel on Multidistrict Litigation on May 30, plaintiff Vera Lee Sellers requested that all cases be centralized for coordinated pretrial proceedings before U.S. District Judge David R. Herndon in the Southern District of Illinois, where at least 8 of the lawsuits are currently pending.

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Sellers’ attorneys indicate in the motion that they anticipate more than 500 additional lawsuits over bleeding problems with Pradaxa will be filed in the near future, and all of the claims arise out of the same or similar wrongful conduct of Boehringer Ingelheim, alleging claims for failure to warn, design defect, manufacturing defect, breach of warranty and claims associated with conduct that imposes liability for the marketing and sale of Pradaxa.

If the motion to consolidate the Pradaxa litigation is granted, all cases filed in federal courts throughout the United States will be transferred to one judge for coordinated handling and to serve the convenience of the parties, witnesses and the courts. Such consolidation is common in complex pharmaceutical litigation, helping reduce duplicative discovery and avoid inconsistent pretrial rulings from different courts.

Although the cases are handled in a coordinated manner, each lawsuit remains an individual case. In the event that a Pradaxa settlement or other resolution for the litigation is not reached during pretrial proceedings, each claim would be remanded back to the federal district court where it was originally filed for an individual trial date.

One of the arguments raised by Sellers for consolidating the Pradaxa litigation before Judge Herndon is his prior experience and success handling large, drug-related MDLs. Judge Herndon is currently presiding over the Yaz and Yasmin litigation, involving claims filed by women who suffered blood clot injuries from the newer birth control pills, which feature the “fourth” generation progestin drospirenone.

Since that MDL was established in October 2009, Judge Herndon has been successful in facilitating Yaz settlement agreements in hundreds of cases.

Pradaxa (dabigitran) is a relatively new anticoagulant that was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of stroke among patients with atrial fibrillation. However, while Coumadin patients who suffer bleeding events, a common problem with blood thinners, can be given a dose of Vitamin K to reverse the drug’s anticoagulant effects, there is no such reversal agent available for Pradaxa, meaning that bleeding events are hard to stop and can often lead to serious injury or death.

A report issued just days ago by the Institute for Safe Medication Practices (ISMP) found that Pradaxa had the most complaints of any drug on the market, by a large margin, according to adverse event reports filed with the FDA in 2011. Those reports included 542 patient deaths, 2,397 reports of hemorrhaging, 644 strokes and 291 cases of acute renal (kidney) failure. The drug has only been on the market in the U.S. since October 2010.

Some experts say that only a fraction of actual drug adverse events actually gets reported to the FDA, meaning some of those numbers could be significantly higher in reality.


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